UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042810 |
|---|---|
| Receipt number | R000048875 |
| Scientific Title | Japanese study of the effects of vascular access closure on the kidney function in kidney transplant recipients. |
| Date of disclosure of the study information | 2020/12/24 |
| Last modified on | 2021/06/29 20:59:19 |
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Basic information
Public title
Japanese study of the effects of vascular access closure on the kidney function in kidney transplant recipients.
Acronym
JACKTR-Study
Scientific Title
Japanese study of the effects of vascular access closure on the kidney function in kidney transplant recipients.
Scientific Title:Acronym
JACKTR-Study
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation for the effects of vascular access closure on the kidney function in kidney transplant recipients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal function
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
from 2000.9 to 2020.9
stable out patient (renal transplant rescipients)
post operation of vascular access closure (more than 2 years)
Key exclusion criteria
1.uncontrol malignant disease.
2.chronic inflammatory disease
3.chronic infectious disease
4.Child-Pugh Grade C liver cirrhosis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Naganuma |
Organization
Osaka City University
Division name
Department of Urology
Zip code
545-8586
Address
1-4-3 asahi-machi, abenno-ku, Osaka Cuty
TEL
06-6645-3857
spxd48k9@aria.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Naganuma |
Organization
Osaka City University
Division name
Department of Urology
Zip code
545-8586
Address
1-4-3 asahi-machi, abenno-ku, Osaka Cuty
TEL
06-6645-3857
Homepage URL
spxd48k9@aria.ocn.ne.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Clinical Renal Transplantation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Urology, Osaka City University
Address
1-4-3 asahi-machi, abeno-ku, Osaka Cuty
Tel
06-6645-3857
spxd48k9@aria.ocn.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪市立大学医学部附属病院、北里大学医学部附属病院、長崎大学医学部附属病院、奈良県立大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
with RED-Cap system
Management information
Registered date
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048875
